Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B)

Phase 3

Terminated

• Conditions: Behcet's Uveitis
• Interventions: Drug: Placebo; Drug: Gevokizumab

• Registration Number: NCT01965145
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis exacerbations

Detailed Description

A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-18
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria.
• History of Behçet's disease uveitis with ocular involvement of the posterior segment.
• Patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug.
• Male or female, age ≥18 (or legal age of majority in the country) at selection
• For subjects with reproductive potential, a willingness to use highly effective contraceptive measures

Exclusion Criteria

• Infectious uveitis, uveitis due to causes other than Behçet's disease.
• Monocular vision
• Presence of severe cataract or severe posterior capsular opacification.
• Contraindication to mydriasis or presence of posterior synechiae.
• Active TB disease.
• History of severe allergic or anaphylactic reactions to monoclonal antibodies
• History of malignancy within 5 years prior to Selection.

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Solution for subcutaneous injection, placebo
Gevokizumab	Gevokizumab	Solution for subcutaneous injection, Dose 1

Primary Outcome Measures

Name	Time	Method
Time to first acute ocular exacerbation	up to 3 years	number of days

Trial Locations

Locations (2)

Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

St Thomas' Hospital; 🇬🇧 London, United Kingdom